Offering Full Services

Regulatory Strategy

Your regulatory strategy defines the most direct path to achieve your project objectives. Together, let’s maximize compliance, expedite product Commercialization, and save you time and money!

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Regulatory Submission

Your regulatory submissions are too important for anything shy of the most thorough examination for completeness and accuracy.

While we’re at it, let’s clearly demonstrate safety, efficacy, and regulatory compliance so your product can be cleared for market quickly and efficiently.

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Quality Systems and Compliance

Your quality system should be scaled to the size, activity, and requirements for your company.

That way, we can focus on product safety outcomes and be ready to respond rapidly in the unlikely event of crisis.

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Audit Management

Your audit management can make the difference between a clean bill of health and a 483, warning letter, or worse.

Preparing for audits, conducting internal and supplier audits, managing an audit when FDA knocks on your door: If it’s got the word “audit” in it, we’re your team.

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Due Diligence

Your due diligence starts with a product pathway assessment and an extensive review of your documentation.

We do these to mitigate your liabilities and risks because you surely don’t need any costly remediation in your life.

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Technical Support

Your technical support is best delegated to the Lean RAQA team. That is, unless you enjoy staying current on every risk, usability, engineering, testing, reporting, and other protocols! We’ve got this.

You go on and focus on winning in the market.

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Your grief counseling

Part of my job is, you guessed it, grief counseling, because dealing with regulators can be emotionally draining.

I’ll help you arrive at grief stage five (acceptance) quicker because you’ll have a steady hand at your side at all times.

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Completely Free. No Commitments.

Regulatory Pathways Assessment Guide

The RA part

Completely Free. No Commitments.

Regulatory Pathways Assessment Guide

This 17-page Regulatory Pathways Assessment guide (now updated with EU MDR requirements) is probably the most helpful tool I ever created.

Hundreds of downloads later, I confidently assert the guide will help you work through project feasibility and requirements with FDA and notified bodies.

And I promise I won’t spam you. Spam is a waste of everyone’s time.

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Completely Free. No Commitments.

Business

Market Assessment Guide

The BA part

Completely Free. No Commitments.

Business Market Assessment Guide

Regulatory compliance is a critical investment. Initial and recurring expenses take a big chunk out of your budget.

Is it worth it? Only you can answer that question, but we can help.

Our new Market Assessment tool walks you through the revenue vs. cost modeling calculations that can help you judge the market viability of your product – before you commit.

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Completely Free. No Commitments.

21 CFR 820 Roles and Responsibilities Guide

The QA part

Completely Free. No Commitments.

21 CFR 820 Roles/ Responsibilities Guide

“The buck stops here.”

Even if another company is designing, making, and distributing your device – your quality system requirements apply to you. Authority over your device cannot be outsourced.

This 21 CFR 820 Roles and Responsibilities Guide is a tool to identify who’s responsible for complying with what. You can even attach it to your quality agreement.

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What Our Clients Have to Say…

"A “no shit” expert."

Michelle is a “no shit” expert in helping start-up companies with FDA. She sits on an FDA advisory committee, helped

Dr. Mark Adkins

Founder, AK Collaborations

Dr. Mark Adkins

"Before Oprah came Michelle"

Way before Oprah selected our gLOVE treat for her O List, and way before Paraffin quadrupled in size, there was

Nate Curran

COO, Paraffin International

Nate Curran

"Confidence I was ‘doing everything right’"

Michelle’s Regulatory Pathway Assessment helped me get investment proposals, reliable cost estimates, and the confidence I was “doing everything right.”

Bill Lear

President, JULVIA

Bill Lear

"Expert on everything from labels to claims."

Michelle was very helpful on my PepsiCo project. So much so, I let my clients know I have an expert

Jonathan Tofel

CEO/Founder Mission Field

Jonathan Tofel

"Fastest audit ever!"

That was literally the fastest FDA Audit/Inspection “ever!” He arrived, in uniform, at 9:40am and left at 10:30am with no

David Amrhein

President and COO, NovaFlux

David Amrhein

"From zero to 60!"

From zero to 60. Michelle is fast and good. In under two weeks, her due diligence helped us decide if

Jeff Bradford

VP, Global Marketing Clinical Innovations

Jeff Bradford

"Highly collaborative!"

lean RAQA is highly collaborative, which is precisely what you need for a strategy instead of a bunch of regulatory

Marc Lawrence

CEO, KynderMed

Marc Lawrence

"Knowledgeable, professional, and I enjoy her!"

Michelle provided us with an excellent quality system plan. She’s knowledgeable, professional, and I enjoy her!

Jen Watson Koevary

COO, Avery Therapeutics

Jen Watson Koevary

"Right the first time!"

Talking with Michelle Lott, it was immediately clear establishing a new quality management system from scratch (with her) was the

Matt Likens

President and CEO, GT Medical

Matt Likens

"Some kind of ‘Wonder Woman!’"

Michelle is some kind of “Wonder Woman.” How else to describe her layered risk-management remediation plan that weathered three days,

Peter Barthe

President and CEO, Ardent Sound

Peter Barthe

"Thank God for Michelle."

She kept our regulatory strategy on track despite our changing priorities, business goals, and management team!

Ryan Lohrenz

CEO, SalutarisMD

Ryan Lohrenz

"The Best Regulatory Affairs Consultant"

Michelle is the best regulatory affairs consultant I have found in Arizona, maybe beyond. She is very experienced in drugs

Kevin Weber

Principal, Skysis

Kevin Weber

"Top notch."

Michelle Lott is my absolute definite go-to for FDA consultation and regulatory support. In my experience so far, she is

Dr. Patrick Marcus

President, Marcus Engineering

Dr. Patrick Marcus

"What a worthwhile investment!"

We brought Michelle for full-day risk management training and got much more, including an insight on IVDR requirements that we

Bobbi Lilek

Quality Director HTG Molecular

Bobbi Lilek

"Without additional resources or effort!"

By creating procedures and documentation around existing but previously undocumented processes, Michelle developed an easy-to-use, implement, and maintain system without